Multistate outbreak of fungal meningitis and other infections
Laboratory Testing and Results
[12-12-2012] FDA and CDC have identified bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC. These include bacteria known as Bacillus, and fungal species including Aspergillus tubingensis, Aspergillus fumigatus, Cladosporium species,and Penicillium species. Although rare, some of the identified Bacillus species can be human pathogens. Some of the fungal organisms identified, particularly Aspergillus fumigatus, are known to cause disease in humans. It is not known how product contamination with these organisms could affect patients clinically. See CDC’s Advice for Clinicians.
CDC and FDA Laboratory-Confirmed Organisms from Product Samples
Laboratory-Confirmed Organisms from Product Samples Associated with
NECC Recalled Lots of Betamethasone, Cardioplegia, and Triamcinolone Solutions
| Medication | Lot Number | Bacterial and Fungal Contamination |
|---|---|---|
| Betamethasone 6 mg/mL injectable –5 mL per vial |
08202012@141 | Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacini, Kocuria rosea, Bacillus lentus |
| Betamethasone 6 mg/mL injectable –5 mL per vial |
07032012@22 | Bacillus niabensis, Bacillus circulans |
| Betamethasone 12 mg/mL injectable – 5 mL per vial |
07302012@52 | Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis |
| Betamethasone 6mg/mL injectable – 5 mL per vial |
08202012@44 | Bacillus lentus, Bacillus firmus, Bacillus pumilus |
| Betamethasone 6 mg/mL injectable – 5 mL per vial |
08152012@84 | Penicillium sp., Cladosporium sp. |
Triamcinolone 40mg/mL injectable – 1 mL per vial |
06062012@6 | Bacillus lentus, Bacillus circulans, Bacillus niabensis, Bacillus nealsonii, Bacillus subtilis group, Bacillus firmus |
| Triamcinolone 40 mg/mL injectable – 2 mL per vial |
08172012@60 | Aspergillus tubingensis, Penicillium sp. |
| Triamcinolone 40mg/mL injectable – 10 mL per vial |
08242012@2 | Aspergillus fumigatus |
| Cardioplegia solution 265.5 mL per bag |
09242012@55 | Bacillus halmapalus/horikoshii, Brevibacillus choshinensis |
Related Information
- FDA Form 483 for New England Compounding Center
- Meningitis Outbreak: Voriconazole IV availability information
Resources
- Patient Notification Letter
- FDA Voice: We're Working to Offset Ameridose Impact
- FDA Voice: State and Local Partnerships Are Crucial
NECC Information
- New England Compounding Center (NECC) Customer List Since 5/21/2012, Sorted by State - No Product Information
- New England Compounding Center (NECC) Customer List Since 5/21/2012, Sorted by Customer - With Product Information